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Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01475981
First Posted: November 22, 2011
Last Update Posted: November 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Akros Pharma Inc.
  Purpose
The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects.

Condition Intervention Phase
Healthy Drug: JTK-853 or Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized,Double-blind,Placebo-controlled,Ascending Dose Part Evaluating Safety,Tolerability and Pharmacokinetics (PK) of JTK-853 (Fasted/Fed) and Randomized,Open-label,Crossover Part Evaluating Food Effect on PK in Healthy Male Subjects

Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: 1 week ]
  • Maximum concentration (Cmax) of JTK-853 and metabolite M2 [ Time Frame: 1 week ]
  • Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2 [ Time Frame: 1 week ]
  • Area under the concentration-time curve from the time of dosing to the last quantifiable time point (AUClast) for JTK-853 and metabolite M2 [ Time Frame: 1 week ]
  • Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2 [ Time Frame: 1 week ]
  • Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2 [ Time Frame: 1 week ]

Enrollment: 70
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 JTK-853 (fasted condition) Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition
Experimental: Dose 2 JTK-853 (fasted condition) Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition
Experimental: Dose 3 JTK-853 (fasted condition) Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition
Experimental: Dose 2 JTK-853 (fed condition) Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition
Experimental: Dose 3 JTK-853 (fed condition) Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition
Experimental: Dose 4 JTK-853 (fed condition) Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition
Experimental: Dose 5 JTK-853 (fed condition) Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition
Experimental: Dose 6 JTK-853 (fed condition) Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition
Experimental: Dose 7 JTK-853 (fed condition) Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition
Experimental: Dose 5 JTK-853 (high-fat fed condition) Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition
Placebo Comparator: Placebo Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Body mass index (BMI) of 18-30 kg/m2 (inclusive)
  2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit

Exclusion Criteria:

  1. History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
  2. Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen), within 4 weeks prior to the Day before dosing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475981


Locations
United States, Texas
PPD, Phase I Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Akros Pharma Inc.
Investigators
Study Director: Shoji Hoshino, D.V.M Akros Pharma Inc.
  More Information

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT01475981     History of Changes
Other Study ID Numbers: AK853-U-09-001
First Submitted: November 9, 2011
First Posted: November 22, 2011
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Akros Pharma Inc.:
JTK-853
single dose